Management of temporomandibular joint arthropathy: comparison of three non-invasive protocols

ISRCTN	ISRCTN15536327
DOI	https://doi.org/10.1186/ISRCTN15536327
Secondary identifying numbers	Prot. No. 575-2018

Submission date: 30/04/2024
Registration date: 09/09/2024
Last edited: 09/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Temporomandibular joint (TMJ) disc displacement with reduction and intermittent locking is a common issue where the jaw joint's disc moves out of place. This can lead to temporary limited jaw movement but usually resolves without treatment. This study will compare three different treatments to see which is most effective for managing this condition.

Who can participate?
Participants aged 18 years and over with TMJ disc displacement with reduction and intermittent locking

What does the study involve?
Participants are randomly allocated to a standard splint protocol (Group 1), a modified occlusal splint protocol (Group 2), or conventional physical therapy with exercises (Group 3). The first follow-up visit takes place after 1 month of therapy and after 1, 2, 3 and 4 years.

What are the possible benefits and risks of participating?
Participants may benefit from reduced symptoms (pain and intermittent locking). The risks include worsening of symptoms.

Where is the study run from?
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (Italy)

When is the study starting and how long is it expected to run for?
March 2018 to March 2024

Who is funding the study?
This study was funded by the Italian Ministry of Health – Current Research IRCCS

Who is the main contact?
Prof. Gianluca Martino Tartaglia, gianluca.tartaglia@unimi.it

Contact information

Dr Funda Goker
Scientific

Via della Commenda 10
Milano
20122
Italy

ORCID ID	0000-0002-2354-361X
Phone	+39 (0)2 50320236
Email	funda.goker@unimi.it

Prof Gianluca Tartaglia
Public, Scientific, Principal Investigator

Via della Commenda 10
Milan
20122
Italy

Phone	+39 (0)250320236
Email	gianluca.tartaglia@unimi.it

Study information

Study design	Single-blind randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Dental clinic
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Comparison of modified occlusal splint and conventional physical therapy in the management of temporomandibular joint disc displacement with reduction and intermittent locking: a randomized controlled trial
Study acronym	DDwRwIL management
Study hypothesis	The modified mandibular splint can be an effective alternative for the treatment of temporomandibular joint (TMJ) disc displacement with reduction and intermittent locking.
Ethics approval(s)	Approved 17/07/2018, Ethics Committee of Area 2 Milano (Via Francesco Sforza, 28, Milano, 20122, Italy; +39 (0)255032982; federica.massacesi@policlinico.mi.it), ref: Prot. No. 575-2018
Condition	Temporomandibular joint disc displacement with reduction and intermittent locking
Intervention	The effectiveness of standard splint protocol (Group 1) modified occlusal splint protocol (Group 2), and conventional physical therapy with exercises (Group 3) will be compared. Patients shall be randomly assigned by computer-generated allocation sequence (1:1) to receive rehabilitation using conventional therapy approaches or modified occlusal splint protocol or disc re-modelling exercises. The first follow-up visit will take place after 1 month of therapy and after 1, 2, 3 and 4 years. Image analysis will involve the evaluation of morphology and function of intra-articular structures. The outcome will be defined as the disappearance of the pain and the intermittent locking.
Intervention type	Other
Primary outcome measure	Pain at rest and mastication assessed using a Visual Analogue Scale (VAS) from 0 to 10, the extremes of which were ‘no pain’ and ‘pain as bad as the patient ever experienced’ at baseline, 1 year (T1), 2 years (T2), 3 years (T3), 4 years (T4)
Secondary outcome measures	1. Mastication competence assessed using a VAS from 0 to 10, the extremes of which were ‘eating only semi-liquid food’ and ‘eating solid hard food’, at baseline, 1 year (T1), 2 years (T2), 3 years (T3), 4 years (T4) 2. Functional limitation during usual jaw movements assessed using a Likert-type scale (0 - absent, 1 - slight, 2 - moderate, 3 - intense, 4 - severe) at baseline (T0) and the T1 after one year, 2 years (T2), 3 years (T3), and after 4 years (T4)
Overall study start date	18/03/2018
Overall study end date	18/03/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	99 Years
Sex	Both
Target number of participants	45
Participant inclusion criteria	1. Joint sounds and impairment of jaw movements 2. A positive diagnosis of TMJ disc displacement with reduction and intermittent locking (DDwRwIL) based on clinical inspection 3. Patients of DDwR with intermittent locking confirmed by MRI examination 4. Adults (≥18 years) 5. Able to give informed consent
Participant exclusion criteria	1. Contraindication for MRI (such as patients with any metallic prosthesis or artificial pacemakers) 2. TMJ disc displacement without reduction (DDWoR) 3. Previous facial bone fracture 4. If they had already received any treatment before the MRI
Recruitment start date	18/10/2018
Recruitment end date	18/03/2020

Locations

Countries of recruitment

Italy

Study participating centre

Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico

via Francesco Sforza 35
Milan
20122
Italy

Sponsor information

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Hospital/treatment centre

Via Sforza 35
Milan
20122
Italy

Phone	+39 (0)250320236
Email	gianluca.tartaglia@unimi.it
Website	http://www.policlinico.mi.it/
"ROR"	https://ror.org/016zn0y21

Funders

Funder type

Government

Ministero della Salute
Government organisation / National government

Alternative name(s): Italian Ministry of Health, Italy Ministry of Health, Ministry of Health of Italy, Ministry of Health - Italy, Ministry of Health, Italy
Location: Italy

Results and Publications

Intention to publish date	18/03/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The researchers plan to publish the results possibly within 1 year of the study's conclusion
IPD sharing plan	The datasets generated during this study will be available upon request from Gianluca Martino Tartaglia (gianluca.tartaglia@unimi.it). The type of data that will be shared: raw data Excel tables. Dates of availability: upon publication. The dataset of the patients has been stripped of any personally identifiable information such as names, addresses and phone numbers.

Editorial Notes

09/05/2024: Study's existence confirmed by the Ethics Committee of Area 2 Milano.